Feropur

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to the EU RAR for Sodium Hydroxide (2007; section 4.1.2.3.2), a Klimisch 1 reliability score was assigned since the study is conducted in accordance with the GLP guideline.

Data source

Reference

Reference Type:

publication

Title:

OECD Eye Irritation Tests on Sodium Hydroxide

Author:

Jacobs GA

Year:

1992

Bibliographic source:

J Amer Coll Toxicol, 11, 725

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

not specified

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): NaOH
- Physical state: NaOH solution

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount of substance instilled: 0.1 ml into the lower conjunctival sac
- Concentration (if solution): 2.0% and 1.0%

Observation period (in vivo):

4 hr, 24 hr, 48 hr, 72 hr and 96 hr

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM: Draize scoring criteria, according to OECD 405

TOOL USED TO ASSESS SCORE: one drop of 2% sodium fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

Conjunctivitis

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

> 2.5

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: Result for 2% NaOH. Details see remarks on results including tables and figures

Results 2

Irritation parameter:

cornea opacity score

Remarks:

corneal opacity

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

> 2

Max. score:

4

Reversibility:

other: Corneal injury had not changed substantially but are of eye covered had been drastically reduced

Remarks on result:

other: Result for 2% NaOH. Details see remarks on results including tables and figures

Irritant / corrosive response data:

A 2% NaOH solution caused moderate corneal injury (mean 2.0 for a maximum score of 4) which covered approx. half of the cornea. By 96 hours, the corneal injury had not changed substantially but the area of the eye covered had been drastically reduced. Severe conjunctival irritation was also observed between 4 and 96 hours at this concentration. The effects observed with a 1% solution were less than that observed with the 2% solution.

Any other information on results incl. tables

Results for NaOH 2%:

Time after application:	4 Hr	24 Hr	48 Hr	72 Hr	96 Hr
Mean Score of Conjunctivitis (3 maximum):	2.8	3.0	3.0	3.0	3.0
Mean Score of Chemosis (4 maximum):	2.0	2.0	1.7	0.7	0.3
Mean Score of Iritis (2 maximum):	1.0	1.0	1.0	0.7	0.3
Mean Score of Corneal Opacity (4 maximum):	2.0	2.0	2.0	2.33	1.7
Mean Surface of Corneal Damage (100% maximum)	56	33	21	10	4

Classification according to the EC criteria: Irritating to eyes (mean over 24/78/72 Hrs for conjunctivitis > 2.5, mean of opacity over 24, 48, 72 Hrs > 2)

Results for NaOH 1%:

Time after application:	4 Hr	24 Hr	48 Hr	72 Hr	96 Hr
Mean Score of Conjunctivitis (3 maximum):	2.0	2.5	2.11	1.72	1.4
Mean Score of Chemosis (4 maximum):	1.5	1.0	0.7	0.2	0.2
Mean Score of Iritis (2 maximum):	0.8	0.5	0.3	0.3	0.0
Mean Score of Corneal Opacity (4 maximum):	0.3	1.0	1.3	0.8	0.3
Mean Surface of Corneal Damage (100% maximum):	27	19	8	5	2

Classification according to the EC criteria: Not irritating to the eyes

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information 2% solution of NaOH